Next Article in Journal
A Stability-Indicating HPLC Method for the Determination of Memantine Hydrochloride in Dosage Forms through Derivatization with 1-Fluoro-2,4-dinitrobenzene
Previous Article in Journal
An Update on the Status of Potent Inhibitors of Metallo-β-Lactamases
 
 
Search for Articles:
Title / Keyword
Author / Affiliation / Email
Journal
Article Type
 
 
Advanced Search
 
Section
Special Issue
Volume
Issue
Number
Page
 
Journals
Sci. Pharm.
Volume 82
Issue 2
10.3797/scipharm.1310-21
scipharm-logo
Submit to this Journal Review for this Journal Propose a Special Issue
► Article Menu

Article Menu

share Share announcement Help format_quote Cite question_answer Discuss in SciProfiles thumb_up
...
Endorse textsms
...
Comment
Scientia Pharmaceutica is published by MDPI from Volume 84 Issue 3 (2016). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Austrian Pharmaceutical Society (Österreichische Pharmazeutische Gesellschaft, ÖPhG).
first_page
settings
Order Article Reprints
Font Type:
Arial Georgia Verdana
Font Size:
Aa Aa Aa
Line Spacing:
Column Width:
Background:
Article

Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques

by
Veera Raghava Raju THUMMALA
1,*,
Mrutyunjaya Rao IVATURI
2 and
Someswara Rao NITTALA
2
1
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
2
School of Chemistry, Andhra University, Visakhapatnam-530003, A.P., India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2014, 82(2), 247-264; https://doi.org/10.3797/scipharm.1310-21
Submission received: 24 October 2013 / Accepted: 12 January 2014 / Published: 12 January 2014
Versions Notes

Abstract

This study details the isolation, identification, and characterization of ambroxol’s unknown impurity. One unknown impurity of ambroxol was formed in the formulated drug under stress conditions [40°C /75% relative humidity (RH) for 6 months] with the relative retention time (RRT) 0.68 in RP-HPLC. The impurity was enriched by exposing it to heat and it was isolated by using preparative HPLC. The enriched impurity was purified and characterized using the following sophisticated techniques: 2D NMR (gDQ-COSY, gHSQC, and gHMBC), FTIR, and LC-MS/MS. On the basis of the spectral data, the impurity was characterized as trans-4-(6,8-dibromoquinazolin-3(4H)-yl)cyclohexanol.
Keywords: Ambroxol; RP-HPLC; Unknown impurity; NMR; LC-MS/MS Ambroxol; RP-HPLC; Unknown impurity; NMR; LC-MS/MS

Share and Cite

MDPI and ACS Style

THUMMALA, V.R.R.; IVATURI, M.R.; NITTALA, S.R. Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques. Sci. Pharm. 2014, 82, 247-264. https://doi.org/10.3797/scipharm.1310-21

AMA Style

THUMMALA VRR, IVATURI MR, NITTALA SR. Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques. Scientia Pharmaceutica. 2014; 82(2):247-264. https://doi.org/10.3797/scipharm.1310-21

Chicago/Turabian Style

THUMMALA, Veera Raghava Raju, Mrutyunjaya Rao IVATURI, and Someswara Rao NITTALA. 2014. "Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques" Scientia Pharmaceutica 82, no. 2: 247-264. https://doi.org/10.3797/scipharm.1310-21

Article Metrics

Back to TopTop